Paragon 8F Balloon Guide Cathete

GUDID 06970908212109

Shanghai Wallaby Medical Technologies Co., Inc.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 06970908212109
• NIH Device Record Key: 518197ad-2e1b-4e71-8210-0fb92a7895fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon 8F Balloon Guide Cathete
• Version Model Number: BG8F095
• Company DUNS: 544535295
• Company Name: Shanghai Wallaby Medical Technologies Co., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970908212109 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-21
• Device Publish Date: 2024-10-11

On-Brand Devices [Paragon 8F Balloon Guide Cathete]

• 06970908212109: BG8F095
• 06970908212093: BG8F085